MDACS Activities
Replacing the term “Make” with “Manufacturer” under the Medical Device Administrative Control System (MDACS)
28 Mar 2024
Starting from 2 April 2024, the term “Make” has been replaced with “Manufacturer” under MDACS. The definition of “Manufacturer” stipulated in Guidance Notes GN-00 remains unchanged.
The following updated Guidance Notes, Code of Practice and Forms in response to the above changes are uploaded to our website (www.mdd.gov.hk):
- Guidance Notes: GN-01, GN-02, GN-03, GN-04, GN-06, GN-07, GN-08, GN-09
- Code of Practice: COP-01, COP-02, COP-03, COP-04, COP-05
- Forms: MD-IP+D, MD101, MD102, MD107, MD-CCL, MDIVD-CCL, AIR-LRP, MD108, MD-Renewal, MD110